metastatic colorectal cancer market insight

DelveInsight’s ‘Metastatic Colorectal Cancer (mCRC) - Market Insights, Epidemiology and Market Forecast– 2030’ report delivers an in-depth understanding of the mCRC, historical and forecasted epidemiology as well as the mCRC market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

The mCRC market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM mCRC market size from 2018 to 2030. The report also covers current mCRC treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2018–2030

Metastatic Colorectal Cancer (mCRC) Disease Understanding and Treatment Algorithm

Metastatic Colorectal Cancer (mCRC) Overview

Colorectal cancer (CRC) is the third most common, with metastasis being the major cause of death in the majority of patients. CRC starts in the colon or the rectum. These cancers can also be called colon cancer or rectal cancer, depending on where they start. Colon cancer and rectal cancer are often grouped together because they have many features in common. CRC may develop when polyps, mushroom-like growths inside the colon, grow and become cancerous or cells along the lining of the colon or rectum mutate and grow out of control, forming a tumor.

CRC that spreads, or metastasizes, to the lungs, liver or any other organ is called metastatic colorectal cancer (mCRC). The most common site of metastases for colon or rectal cancer is the liver. CRC cells may also spread to the lungs, bones, brain, or spinal cord. If a person has been treated for CRC and cancer cells have been found in these areas, it may be a sign that the original CRC has spread. mCRC is different from recurrent CRC.

Generally, most CRCs (95%) are considered sporadic, meaning the genetic changes develop by chance after a person is born, so there is no risk of passing these genetic changes on to one’s children. Inherited CRCs are less common (5%) and occur when gene mutations, or changes, are passed within a family from one generation to the next. Often, the cause of CRC is not known.

Most CRCs start as a growth on the inner lining of the colon or rectum. These growths are called polyps. Some types of polyps can change into cancer over time (usually many years), but not all polyps become cancer. The chance of a polyp turning into cancer depends on the type of polyp it is.

If cancer forms in a polyp, it can grow into the wall of the colon or rectum over time. The wall of the colon and rectum is made up of many layers. CRC starts in the innermost layer (the mucosa) and can grow outward through some or all of the other layers. When cancer cells are in the wall, they can then grow into blood vessels or lymph vessels (tiny channels that carry away waste and fluid). From there, they can travel to nearby lymph nodes or distant parts of the body. The stage (extent of spread) of a CRC depends on how deeply it grows into the wall and if it has spread outside the colon or rectum.

Metastatic Colorectal Cancer (mCRC) Diagnosis

Approximately one-fifth of CRC cases are metastatic at the time of diagnosis. Patients can present with a wide range of signs and symptoms such as occult or overt rectal bleeding, change in bowel habits, anemia, or abdominal pain. However, CRC is largely an asymptomatic disease until it reaches an advanced stage. By contrast, rectal bleeding is a common symptom of both benign and malignant causes. Therefore additional risk factors might be needed to help identify those people who should undergo further investigation by colonoscopy. New-onset rectal bleeding should generally prompt colonoscopy in individuals aged 45 years or older. In younger patients, additional factors are used to identify those at highest risk for CRC (e.g., having a family history of CRC, change in bowel habits, unexplained weight loss, and blood mixed with the stool as opposed to blood on the surface of the stool).

Metastatic Colorectal Cancer (mCRC) Treatment

Metastatic CRC is still an incurable disease for most of the patients, with most commonly liver, lung or lymph nodes and peritoneal metastases. In the past, 15 years ago, median overall survival (mOS) was approximately 12 months, and the 5-year survival rate was 13%. However, the survival rate of these patients has increased, mainly due to the combined treatment of metastases with surgery and systemic therapy. Long-term survival or even cure can be attained in 20–50% of the patients who undergo complete R0 resection of liver or lung metastases, and around 70% 5-year survival of these patients can be achieved.

However, in the field of systemic therapy, there has been significant progress with new drugs in recent years. There are more options of initial systemic chemotherapy, oxaliplatin, irinotecan, and fluoropyrimidines, in combination with targeted therapy with anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (cetuximab, panitumumab) in case of KRAS wild type tumors or anti-vascular endothelial growth factor (VEGF) inhibitors (monoclonal antibodies bevacizumab, aflibercept, ramucirumab, regorafenib as per oral tyrosine kinase inhibitor). The combination of these novel chemotherapies and targeted therapy now extends the mOS up to 40 months.

The treatment plan may include a combination of surgery, radiation therapy, immunotherapy, and chemotherapy, which can be used to slow the spread of the disease and often temporarily shrink a cancerous tumor. Palliative care will also be important to help relieve symptoms and side effects. At this stage, surgery to remove the portion of the colon where cancer started usually cannot cure cancer, but it can help relieve the blockage of the colon or other problems related to cancer. Surgery may also be used to remove parts of other organs that contain cancer, called resection, and can cure some people if a limited amount of cancer spreads to a single organ, such as the liver or a lung. If the CRC has spread only to the liver and if surgery is possible—either before or after chemotherapy—there is a chance of complete cure. Even when curing the cancer is not possible, surgery may add months or even years to a person’s life.

Metastatic Colorectal Cancer (mCRC) Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Incident Population of Colorectal Cancer, and Incident Population of Metastatic Colorectal Cancer (mCRC) in the 7MM market covering the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom) and Japan from 2018 to 2030.

Key Findings

This section provides glimpse of the CRC epidemiology in the 7MM.

• The incident population of CRC in the seven major markets was 532,433 in 2020.
• In the 7MM, the highest number of incident cases of Colorectal Cancer was observed in the US, with 146,589 cases in the year 2020.
• In the year 2020, the total incident cases of metastatic colorectal cancer were 207,873 cases in the 7MM.
• In the EU-5 countries the incident cases of metastatic colorectal cancer were 92,889 cases in the year 2020, with highest cases being reported in Germany.

Country-wise Metastatic Colorectal Cancer (mCRC) Epidemiology

The epidemiology segment also provides the Metastatic Colorectal Cancer (mCRC) epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.

Metastatic Colorectal Cancer (mCRC) Drug Chapters

The drug chapter segment of the Metastatic Colorectal Cancer (mCRC) report encloses the detailed analysis of Metastatic Colorectal Cancer (mCRC) marketed drugs and mid and late stage pipeline drugs. It also helps to understand the Metastatic Colorectal Cancer (mCRC) clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details of each included drug and the latest news and press releases.

Metastatic Colorectal Cancer (mCRC) Marketed Drugs

Keytruda (pembrolizumab) injection: Merck

Keytruda is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. The drug is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1, and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. There are currently more than 1,200 trials studying Keytruda across a wide variety of cancers and treatment settings. In June 2020, the US FDA approved Keytruda for intravenous injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) CRC. The drug is the first immunotherapy approved for this patient population as a first-line treatment and which is administered to patients without also giving chemotherapy.

Product details in the report…

Stivarga (Regorafenib): Alexion Pharmaceuticals

Regorafenib has emerged as a treatment option for patients with metastatic colorectal cancer (mCRC) previously exposed to 2 rounds of chemotherapy, supporting the notion that the more treatment options that patients have extending into multiple lines of therapy, the longer their overall survival. The US FDA approved regorafenib for the treatment of patients with mCRC who have previously received fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) therapy, and, if RAS wild-type, an anti–epidermal growth factor receptor (EGFR) therapy.

Product details in the report…

Jemperli (dostarlimab): GlaxoSmithKline (GSK)

Dostarlimab, developed by GSK, is a humanized monoclonal antibody of the IgG4 isotype that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. Recently in 2021, the US FDA granted approval to Jemperli for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours.

Product details in the report…

Braftovi (encorafenib) + Erbitux (cetuximab) ± Mektovi (binimetinib): Array BioPharma/ Pfizer + Pfizer

Braftovi is an oral small-molecule BRAF kinase inhibitor that targets a key enzyme in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, including melanoma, colorectal cancer, and others. While Erbitux is a recombinant, human/mouse chimeric monoclonal antibody. While Mektovi is an oral small molecule MEK inhibitor that targets key enzymes in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Cetuximab is an anticancer agent that works by inhibiting the growth and survival of epidermal growth factor receptor (EGFR)-expressing tumor cells with high specificity and higher affinity than epidermal growth factor (EGF) and transforming growth factor-alpha (TGF-α), which are natural ligands of EGFR. In the US, Braftovi is approved in combination with cetuximab for metastatic colorectal cancer patients with a BRAF V600E mutation

Product details in the report…

The complete list of marketed drugs will be provided in the final report

Metastatic Colorectal Cancer (mCRC) Emerging Drugs

Adagrasib (MRTX849) + cetuximab: Mirati Therapeutics + Merck

Adagrasib (MRTX849) is an investigational, orally available small molecule that is designed to potently and selectively inhibit a form of KRAS which harbors a substitution mutation (G12C). Adagrasib, an optimized KRAS G12C inhibitor, is designed to stop some of the most complex and aggressive cancers in their tracks. It is a potent, highly selective, oral therapy that maximizes inhibition by irreversibly locking the KRAS molecule in its inactive state, thereby preventing tumor cell growth which results in tumor cell death. Currently, the combination of adagrasib and cetuximab is being investigated in a Phase III KRYSTAL-10 trial (NCT04793958), for the treatment of 2L KRAS G12C mutated advanced metastatic Colorectal Cancer patients.

Product details in the report…

MK-4280A (favezelimab and pembrolizumab): Merck

MK-4280A, is a humanized, immunoglobulin G4 (IgG4) monoclonal antibody (MAb) directed against the inhibitory receptor lymphocyte activation gene-3 protein (LAG3), with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, the anti-LAG3 monoclonal antibody MK-4280 binds to LAG3 expressed on tumor-infiltrating lymphocytes (TILs) and blocks it’s binding with major histocompatibility complex (MHC) class II molecules expressed on tumor cells.

Product details in the report…

Elunate (fruquintinib/HMPL-013): Hutchison Medipharma

Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptor (VEGFR) 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. The drug is designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability, and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.

Product details in the report…

Corsela (trilaciclib): G1 Therapeutics

Corsela (Trilaciclib) is a small-molecule, short-acting, inhibitor of cyclin-dependent kinases (CDK) 4 and 6 developed by G1 Therapeutics for its myeloprotection and potential antitumor efficacy and safety benefits in combination with cancer chemotherapy. CDKs govern cell cycle progression, and trilaciclib induces a transient, reversible G1 cell cycle arrest of proliferating hematopoietic stem and progenitor cells in bone marrow, thus protecting them from damage during chemotherapy. It is a novel therapeutic approach, which is given before chemotherapy that temporarily blocks progression through the cell cycle.

Product details in the report…

Modufolin (arfolitixorin): Isofol Medical

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced CRC. As the key active metabolite of the widely used folate-based drugs leucovorin and levoleucovorin, arfolitixorin can potentially benefit all patients with advanced CRC, as it does not require complicated metabolic activation to become effective. Folic acid is converted by the human body into a pool of at least six interconvertible forms of reduced folates. Among the various metabolites involved, the active ingredient contained in arfolitixorin plays the most crucial role as the last reduced folate in the chain, which function as a substrate for the TS enzyme.

Product details in the report…

The complete list of emerging drugs will be provided in the final report

Metastatic Colorectal Cancer (mCRC) Market Outlook

Colorectal cancer (CRC) is the second most frequent type of cancer that represents approximately 12–14% of all cancer cases in men and women. Out of these, approximately 25% of patients present with metastases at initial diagnosis and almost 50% may eventually develop metastases, contributing to the high mortality rates reported for CRC. In order to identify the optimal treatment strategy for patients with mCRC, tumor staging is essential and should include at least clinical examination, blood counts, liver and renal function tests, CEA, and CT scan of the abdomen and chest (or alternatively MRI).

The treatment plan may include a combination of surgery, radiation therapy, immunotherapy, and chemotherapy, which can be used to slow the spread of the disease and often temporarily shrink a cancerous tumor. Palliative care is also important to help relieve symptoms and side effects.

The first, second, and third-line treatment regimen of mCRC involves the use of multi-agent chemotherapy (i.e. FOLFOX, FOLFIRI, CAPEOX), anti-angiogenesis therapy with or without chemotherapy, epidermal growth factor receptor (EGFR) inhibitors with or without chemotherapy, and others with or without chemotherapy. Along with these therapies, Opdivo, with or without Yervoy, and Braftovi, in combination with Erbitux, are approved for the treatment of mCRC patients as the only second and third-line therapies, while Keytruda is approved as the only first-line therapy of mCRC.

Key Findings

The Metastatic Colorectal Cancer market size in the 7MM is expected to change during the study period 2018–2030, at a CAGR of 2.9%. According to the estimates, the highest market size of mCRC is accessed in the United States followed by Japan, in 2020.

The United States Market Outlook

This section provides the total Metastatic Colorectal Cancer (mCRC) market size and market size by therapies in the United States.

EU-5 Market Outlook

The total Metastatic Colorectal Cancer (mCRC) market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

Japan Market Outlook

The total Metastatic Colorectal Cancer (mCRC) market size and market size by therapies in Japan are provided.

Metastatic Colorectal Cancer (mCRC) Drugs Uptake

This section focusses on the rate of uptake of the potential drugs recently launched in the Metastatic Colorectal Cancer (mCRC) market or expected to get launched in the market during the study period 2018–2030. The analysis covers Metastatic Colorectal Cancer (mCRC) market uptake by drugs; patient uptake by therapies; and sales of each drug.

This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allow the comparison of the drugs on the basis of market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Metastatic Colorectal Cancer (mCRC) Development Activities

The report provides insights into different therapeutic candidates in Phase II, and Phase III stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing and patent details for Metastatic Colorectal Cancer (mCRC) emerging therapies.

Competitive Intelligence Analysis

We perform competitive and market Intelligence analysis of the Metastatic Colorectal Cancer (mCRC) market by using various competitive intelligence tools that include–SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

• The report covers the descriptive overview of Metastatic Colorectal Cancer (mCRC), explaining its causes, signs and symptoms, pathogenesis and currently available therapies.
• Comprehensive insight has been provided into the Metastatic Colorectal Cancer (mCRC) epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for Metastatic Colorectal Cancer (mCRC) are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of Metastatic Colorectal Cancer (mCRC) market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM Metastatic Colorectal Cancer (mCRC) market.

Report Highlights

• In the coming years, mCRC market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies and academics are working to assess challenges and seek opportunities that could influence mCRC R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Delvelnsight analysed specific data of mCRC, which suggests that the incidence of mCRC is anticipated to decline during the forecast period.
• Currently, the first, second and third-line treatment regimen of mCRC involves the use of multiagent chemotherapy (i.e. FOLFOX, FOLFIRI, CAPEOX), anti-angiogenesis therapy with or without chemotherapy, Epidermal growth factor receptor (EGFR) inhibitors with or without chemotherapy, Keytruda, Opdivo with or without Yervoy, Braftovi in combination with Erbitux and others with chemotherapy.
• The market space of mCRC would benefitted in the coming years with the launch of several emerging therapies. These therapies include triplet combination of Braftovi + Mektovi + Erbitux, Modufolin (arfolitixorin) + bevacizumab, Adagrasib, Lumakras (sotorasib) + panitumumab, Elunate (fruquintinib), Tukysa (tucatinib) ± Herceptin (trastuzumab), Onvansertib.

Metastatic Colorectal Cancer (mCRC) Report Insights

• Patient Population
• Therapeutic Approaches
• Metastatic Colorectal Cancer (mCRC) Pipeline Analysis
• Metastatic Colorectal Cancer (mCRC) Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Metastatic Colorectal Cancer (mCRC) Report Key Strengths

• Ten Years Forecast
• 7MM Coverage
• Metastatic Colorectal Cancer (mCRC)Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Metastatic Colorectal Cancer (mCRC) Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers

Key Questions

Market Insights:

• What was the Metastatic Colorectal Cancer (mCRC) market share (%) distribution in 2018 and how it would look like in 2030?
• What would be the Metastatic Colorectal Cancer (mCRC) total market size as well as market size by therapies across the 7MM during the forecast period (2021–2030)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest Metastatic Colorectal Cancer (mCRC)market size during the forecast period (2021–2030)?
• At what CAGR, the Metastatic Colorectal Cancer (mCRC) market is expected to grow at the 7MM level during the forecast period (2021–2030)?
• What would be the Metastatic Colorectal Cancer (mCRC) market outlook across the 7MM during the forecast period (2021–2030)?
• What would be the Metastatic Colorectal Cancer (mCRC) market growth till 2030 and what will be the resultant market size in the year 2030?
• How would the market drivers, barriers and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What is the disease risk, burden and unmet needs of Metastatic Colorectal Cancer (mCRC)?
• What is the historical Colorectal Cancer (CRC) patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK) and Japan?
• What is the historical Metastatic Colorectal Cancer (mCRC) patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK) and Japan?
• What would be the forecasted patient pool of Metastatic Colorectal Cancer (mCRC) at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Metastatic Colorectal Cancer (mCRC)?
• Out of the above-mentioned countries, which country would have the highest incident population of Metastatic Colorectal Cancer (mCRC)during the forecast period (2021–2030)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2021–2030)?

Current Treatment Scenario, Marketed Drugs and Emerging Therapies:

• What are the current options for the treatment of Metastatic Colorectal Cancer (mCRC) along with the approved therapy?
• What are the current treatment guidelines for the treatment of Metastatic Colorectal Cancer (mCRC) in the US and Europe?
• What are the Metastatic Colorectal Cancer (mCRC) marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
• How many companies are developing therapies for the treatment of Metastatic Colorectal Cancer (mCRC)?
• How many therapies are developed by each company for the treatment of Metastatic Colorectal Cancer (mCRC)?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of Metastatic Colorectal Cancer (mCRC)?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Metastatic Colorectal Cancer (mCRC) therapies?
• What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Metastatic Colorectal Cancer (mCRC) and their status?
• What are the key designations that have been granted for the emerging therapies for Metastatic Colorectal Cancer (mCRC)?
• What are the 7MM historical and forecasted market of Metastatic Colorectal Cancer (mCRC)?

Reasons to buy

• The report will help in developing business strategies by understanding trends shaping and driving the Metastatic Colorectal Cancer (mCRC).
• To understand the future market competition in the Metastatic Colorectal Cancer (mCRC) market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Metastatic Colorectal Cancer (mCRC) in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom) and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for Metastatic Colorectal Cancer (mCRC) market.
• To understand the future market competition in the Metastatic Colorectal Cancer (mCRC) market.